LEQVIO (inclisiran) US prescribing information (USPI) updates
On February 12, 2026, the FDA approved a new indication for pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia (HeFH), and a new indication for pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH).
The updated indication statement (section 1.0) is as follows:
LEQVIO is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in
- adults with hypercholesterolemia.
- adults and pediatric patients aged 12 years and older with HeFH.
- pediatric patients aged 12 years and older with HoFH.
The first bullet of Recommended Dosage (section 2.1) was revised to include “pediatric patients aged 12 years and older” and is now as follows:
The recommended dosage of LEQVIO for adults and pediatric patients aged 12 years and older is 284 mg administered as a single subcutaneous injection initially, again at 3 months, and then every 6 months.
USPI sections 1, 2.1, 6.1, 8.4, 12.3, 12.6, and 14 have been updated with pediatric HeFH/HoFH information—please see the updated prescribing information here: leqvio.pdf (novartis.com)
Separately, based on post-marketing experience data, the FDA requested modifications to the label regarding hypersensitivity, including the term “anaphylaxis”. Revisions were made to the Contraindications (section 4) and Postmarketing Experience (section 6.2) of the USPI. In addition, hypersensitivity reactions have been added to Warnings and Precautions (section 5) and noted in Patient Counseling Information (section 17).
Contraindications (section 4): LEQVIO is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO. Serious hypersensitivity reactions have included anaphylaxis and angioedema
Hypersensitivity Reactions (section 5.1): Hypersensitivity reactions, including anaphylaxis and angioedema, have been reported in patients treated with LEQVIO. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to seek medical attention promptly. LEQVIO is contraindicated in patients with a prior serious hypersensitivity reaction to inclisiran or any of the excipients in LEQVIO
Postmarketing Experience (section 6.2): Hypersensitivity: anaphylaxis, angioedema, rash, pruritus, and urticaria
Reporting of adverse events, including technical complaints and medication errors, is encouraged by contacting Novartis at 1-888-NOW-NOVA (1-888-669-6682) or the FDA’s MedWatch Adverse Event Reporting Program at www.fda.gov/medwatch or 1-800-FDA-1088.